• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ASPIRATION PUMP MAX 220V JCX

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PENUMBRA, INC. PENUMBRA SYSTEM ASPIRATION PUMP MAX 220V JCX Back to Search Results
Catalog Number PMX220
Device Problems Failure to Pump; Device Operates Differently Than Expected; No Pressure
Event Date 10/16/2016
Event Type  Malfunction  
Manufacturer Narrative

Results: removal of the biohazard bags revealed blood on the pump housing. In addition, dried blood was found in and around the vacuum inlet on the top of the pump. A pipe cleaner was inserted in the pump inlet and blood was observed inside the pump. Conclusions: evaluation of the returned pump revealed blood in and around the pump vacuum inlet. If the aspiration tubing is connected directly to the vacuum inlet rather than the canister supplied by penumbra, blood will likely enter the pump assembly. The observed blood likely contributed to the reported noise and the pump not producing vacuum. Penumbra pumps are visually and functionally inspected during incoming quality inspection. The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

 
Event Description

The patient was undergoing a thrombectomy procedure using a penumbra system aspiration pump max 220v (pump max). During the procedure, the pump max was powered on and a loud high-pitched noise was heard; however, the pump max did not produce any vacuum. Therefore, the procedure was completed by manual aspiration. There was no report of an adverse effect to the patient.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePENUMBRA SYSTEM ASPIRATION PUMP MAX 220V
Type of DeviceJCX
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
Manufacturer Contact
veronica farris
one penumbra place
alameda , CA 94502
5107483200
MDR Report Key6107143
Report Number3005168196-2016-01623
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial
Report Date 10/18/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/16/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue NumberPMX220
Device LOT NumberF18682-17
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/03/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/18/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/27/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-